According to research published in The Lancet Neurology on Feb. 1, daridorexant (50 mg) improves both overnight symptoms and daytime functioning in persons with insomnia conditions.
Two-phase 3 randomized controlled trials were undertaken at 156 sites in 17 countries by Emmanuel Mignot, M.D., of the Stanford Center for Sleep Research and Medicine in Palo Alto, California, and colleagues.
In research 1, 930 adults with insomnia disorder (1:1:1) were randomly assigned to receive either daridorexant (50 mg, 25 mg) or placebo, while in study 2, 924 adults were randomly assigned to receive either daridorexant (25 mg, 10 mg) or placebo every evening for three months.
At month 1 and month 3, the researchers discovered that participants in the daridorexant 50-mg group had significantly lower wake time after sleep onset (WASO) and latency to persistent sleep (LPS) than those in the placebo group.
In comparison to the placebo group, individuals who received daridorexant 25 mg had similar findings for WASO and LPS. At month 1 and month 3, the daridorexant 50-mg group had significantly better self-reported total sleep time and Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) scores than the placebo group.
The daridorexant 25-mg group, on the other hand, found substantial improvements only in self-reported total sleep, not in IDSIQ sleepy domain scores.
At months 1 and 3, WASO was considerably lower in the daridorexant 25-mg group compared to the placebo group in trial 2, but there were no significant differences in LPS. At months 1 and 3, the daridorexant 25-mg group had a substantial improvement in self-reported total sleep time, but not in IDSIQ sleepiness domain scores.
The daridorexant 10-mg group did not show any significant improvements in any of the parameters compared to the placebo group. Across studies, the overall incidence of adverse events was similar between treatment groups.
“It’s fantastic to see that insomnia is finally being recognized as a source of daytime pain, rather than only a nighttime condition,” Mignot said in a statement.
Idorsia Pharmaceuticals, which manufactures daridorexant and funded the study, was one of several authors who declared financial relationships to pharmaceutical corporations.
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